Experience

Ecron Acunova

• Germany
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Assistant Quality Assurance Manager

  • Jun 2018 - Present

  • Oversee the implementation of Quality Management System and GCP within the organization. • Ensure implementation of ISO 9001:2015 and ISO 27001:2013 standards within the organization• Plan and conduct internal audits of Clinical Operations, Clinical Data Management, Medical Affairs, Biostatistics, Regulatory Affairs, Pharmacy, and IT etc. • Plan and conduct external audits including vendor qualification audit and investigator site audit. • Review of documents like SOP, Protocol, Informed Consent Form, Statistical Analysis Plan, Statistical Analysis Report, Clinical Study Report etc. • Management of inspections and external audits conducted by regulatory agency, certification body, and sponsor. • Corrective and Preventive Action management, including review, finalization, implementation and closure of Corrective and Preventive Actions.• Establishment & Monitoring of Quality Metrics.

• Quality Assurance Specialist

  • Nov 2010 - Jun 2018



Manipal Acunova

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Scientist

  • Feb 2008 - Nov 2010

• Scientist

  • 2008 - 2010